Management of temporomandibular joint arthropathy: comparison of three non-invasive protocols
| ISRCTN | ISRCTN15536327 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15536327 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Prot. No. 575-2018 |
| Sponsor | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico |
| Funder | Ministero della Salute |
- Submission date
- 30/04/2024
- Registration date
- 09/09/2024
- Last edited
- 07/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Temporomandibular joint (TMJ) disc displacement with reduction and intermittent locking is a common issue where the jaw joint's disc moves out of place. This can lead to temporary limited jaw movement but usually resolves without treatment. This study will compare three different treatments to see which is most effective for managing this condition.
Who can participate?
Participants aged 18 years and over with TMJ disc displacement with reduction and intermittent locking
What does the study involve?
Participants are randomly allocated to a standard splint protocol (Group 1), a modified occlusal splint protocol (Group 2), or conventional physical therapy with exercises (Group 3). The first follow-up visit takes place after 1 month of therapy and after 1, 2, 3 and 4 years.
What are the possible benefits and risks of participating?
Participants may benefit from reduced symptoms (pain and intermittent locking). The risks include worsening of symptoms.
Where is the study run from?
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (Italy)
When is the study starting and how long is it expected to run for?
March 2018 to March 2024
Who is funding the study?
This study was funded by the Italian Ministry of Health – Current Research IRCCS
Who is the main contact?
Prof. Gianluca Martino Tartaglia, gianluca.tartaglia@unimi.it
Contact information
Scientific
Via della Commenda 10
Milano
20122
Italy
 ORCID ID |
0000-0002-2354-361X |
|---|---|
| Phone | +39 (0)2 50320236 |
| funda.goker@unimi.it |
Public, Scientific, Principal investigator
Via della Commenda 10
Milan
20122
Italy
| Phone | +39 (0)250320236 |
|---|---|
| gianluca.tartaglia@unimi.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of modified occlusal splint and conventional physical therapy in the management of temporomandibular joint disc displacement with reduction and intermittent locking: a randomized controlled trial |
| Study acronym | DDwRwIL management |
| Study objectives | The modified mandibular splint can be an effective alternative for the treatment of temporomandibular joint (TMJ) disc displacement with reduction and intermittent locking. |
| Ethics approval(s) |
Approved 17/07/2018, Ethics Committee of Area 2 Milano (Via Francesco Sforza, 28, Milano, 20122, Italy; +39 (0)255032982; federica.massacesi@policlinico.mi.it), ref: Prot. No. 575-2018 |
| Health condition(s) or problem(s) studied | Temporomandibular joint disc displacement with reduction and intermittent locking |
| Intervention | The effectiveness of standard splint protocol (Group 1) modified occlusal splint protocol (Group 2), and conventional physical therapy with exercises (Group 3) will be compared. Patients shall be randomly assigned by computer-generated allocation sequence (1:1) to receive rehabilitation using conventional therapy approaches or modified occlusal splint protocol or disc re-modelling exercises. The first follow-up visit will take place after 1 month of therapy and after 1, 2, 3 and 4 years. Image analysis will involve the evaluation of morphology and function of intra-articular structures. The outcome will be defined as the disappearance of the pain and the intermittent locking. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain at rest and mastication assessed using a Visual Analogue Scale (VAS) from 0 to 10, the extremes of which were ‘no pain’ and ‘pain as bad as the patient ever experienced’ at baseline, 1 year (T1), 2 years (T2), 3 years (T3), 4 years (T4) |
| Key secondary outcome measure(s) |
1. Mastication competence assessed using a VAS from 0 to 10, the extremes of which were ‘eating only semi-liquid food’ and ‘eating solid hard food’, at baseline, 1 year (T1), 2 years (T2), 3 years (T3), 4 years (T4) |
| Completion date | 18/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Joint sounds and impairment of jaw movements 2. A positive diagnosis of TMJ disc displacement with reduction and intermittent locking (DDwRwIL) based on clinical inspection 3. Patients of DDwR with intermittent locking confirmed by MRI examination 4. Adults (≥18 years) 5. Able to give informed consent |
| Key exclusion criteria | 1. Contraindication for MRI (such as patients with any metallic prosthesis or artificial pacemakers) 2. TMJ disc displacement without reduction (DDWoR) 3. Previous facial bone fracture 4. If they had already received any treatment before the MRI |
| Date of first enrolment | 18/10/2018 |
| Date of final enrolment | 18/03/2020 |
Locations
Countries of recruitment
- Italy
Study participating centre
Milan
20122
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during this study will be available upon request from Gianluca Martino Tartaglia (gianluca.tartaglia@unimi.it). The type of data that will be shared: raw data Excel tables. Dates of availability: upon publication. The dataset of the patients has been stripped of any personally identifiable information such as names, addresses and phone numbers. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/12/2024 | 07/10/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/10/2025: Publication reference added.
09/05/2024: Study's existence confirmed by the Ethics Committee of Area 2 Milano.
